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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Category I: SaMD that provides information to inform clinical management for a disease or condition in a nonserious situation or condition is a Category I and is considered to be of low impact.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Category I: SaMD that provides information to inform clinical management for a disease or condition in a nonserious situation or condition is a Category I and is considered to be of low impact.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

The FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.

FDA 52